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Our first case this morning is Arbiters Bio Pharma Corporation versus Moderna, Tex, Inc.

[00:00:06] Speaker 01:
20-1183.

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Mr. Burrow.

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Mr. Burrow, you have reserved five minutes of your time for rebuttal, correct?

[00:00:19] Speaker 01:
Correct, Your Honor.

[00:00:21] Speaker 01:
Okay.

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You may proceed.

[00:00:24] Speaker 02:
Good morning.

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May it please the Court.

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The board's opinion in this case defies route to branch nearly every foundation of this court's inherent anticipation jurors prudent.

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Counselor, I'm going to kind of jump in here and everything, because you've got limited time, and this is important to us.

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So how would I understand the application of can versus necessary?

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present in this case with respect to inherent dissipation.

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The standard is and always has been that

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claimed invention, here the 95% non-Lamellar particles, necessarily and always must have been present in the prior R composition.

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Not can, not could make, not sufficient to be able to make, necessarily and always present.

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That's been the law since continental can in 1991, and it's recited in every case.

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The ones we cite, like Allergan, the ones that Moderna cites,

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like Smith Klein, that's always the standard, and that's what's lacking here.

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The board never found that.

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The board could not have found that, for the simple reason that the prior art provides no particular composition, no combination of a formulation, the formulation is which lipids and in what amounts, plus a formation process to yield a prior art composition that has the 95% non-lamellar particles.

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That's what's required.

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That's what's missing.

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Before you make these big pronouncements, what's wrong with the idea that the same formulations are identified and described in the 069 and your patent, the 127?

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And both the 127 and the 069, both incorporate by reference the 031, which has the direct dilution method.

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And so therefore, just to the extent that the 127 possesses

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an invention that has this kind of particle composition with this particular property.

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So would the 069 likewise possess and give to the public this kind of particle composition with this kind of property using the direct dilution method?

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The answer, Your Honor, is that there's no such thing as the direct dilution method.

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There is a class or category of methods called direct dilution methods.

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Both parties agree to that.

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Their experts set it at A4044.

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Our patent doesn't just incorporate the 031.

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It incorporates it for general purposes.

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This is how you can do direct dilutions.

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But it says that the particle formation that causes the 95% is as described herein.

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It's not all direct dilution methods, and the board never found that it was.

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There is one and only one place in this entire record

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where there is a discrete direct dilution or stepwise dilution process that yields the claimed particles.

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And that is at column 104 of our patent.

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That is a discrete process.

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Particular solvents, particular buffers, particular mixing conditions, particular equipment, put together in a way that they do not exist in the prior art.

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And don't take my word for it.

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This is what Moderna said before the board.

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Look at their argument before the board.

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It's at A793 to 794.

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And what they say is,

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that there is one guiding principle, not my words, theirs.

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One guiding principle about how one makes these 95% particles.

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And that's at Column 104.

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They call it the secret sauce.

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Again, their words, not mine, that's the secret sauce.

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That's the only place you have a description of an actual process that yields the claimed particles.

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What you have in the prior art and incorporated into our patent is a broad category of processes.

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And that's no different than the situation this court encountered in the Galderma versus Pema case, where the prior art enabled but did not disclose the particular formulation that yielded the efficacy with 1% ivermectin.

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And what this court said in reversing was that.

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So are you saying that table one

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The particular parameters that are identified in Table 1, that's like a unicorn among all the different versions of DDM you could come up with in terms of its ability to yield 95% non-laminar.

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It's not a unicorn in the sense that those are the only parameters that one possibly could use in order to make this morphology We don't assert that it is but it is a unicorn in the sense that that's the only discrete process I didn't I just what I'm saying is I didn't read in this patent anything that suggests that

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Table one is a eureka moment.

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We pulled the needle out of the haystack and found a specific combination of chosen parameter values that are going to yield this super high percentage of non-laminar properties.

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Instead, it feels like you use the direct dilution process.

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That's what you do to get better non-laminar.

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And here's an example of that, table one.

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Well, that's the way it reads to me.

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I don't see anything in this spec that says

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there's a criticality towards what is being chosen here in table 1.

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A few observations, Your Honor.

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First, what we say in column 3 and then again at column 8 is not that all or most direct dilution methods yield a morphology, but rather the direct dilution methods described herein.

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And the only particular method described herein is the one at column 104.

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So whether that's a eureka moment or otherwise, that's the only one.

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I would further observe, and I think this is important, Your Honor,

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that it need not be the only one.

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What this court said in the Knoth case, for example... Well, I know, it need not be the only one.

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Your claim is not limited to that, clearly.

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Your claim encompasses anything that works, anything that produces this great property.

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And the spec seems to show examples of not only direct dilution methods getting you that property, but also step dilution also getting you that property.

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So it's making it less and less clear that there's something uniquely special about whatever you're identifying in table 1 for direct dilution.

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Well, first of all, the stepwise dilution method with some formulations was shown to produce 95% non-Limone.

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And that's accomplished by claim 1.

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Those are indeed, that's a particular stepwise dilution method, not all stepwise dilution methods, a particular one set forth in column 104, which Moderna called the super soft.

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I guess my point is, is that your theme that there has to be one very specific pathway to get you the 95% property and that was

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described in Table 1, that seems to break down when you, in fact, have something like step dilution methods also getting you this same property, which, as you describe in your patent, makes it less likely you're going to get a very high 95% non-laminar morphology compared to direct dilution methods.

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So if you can get it through the step dilution method,

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It's making it less clear to me why only a very, very particular chosen set of parameters for direct dilution method will get you those properties.

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Well, it's only one particular stepwise dilution method that is shown sometimes with some formulations to produce the non-laminar morphology.

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That's the one set forth in column 104.

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But I think the patent is very clear.

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that the particular parameters that are chosen for the formation process are important in determining what morphology results.

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We say that at the beginning of our description of the invention in column two.

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We say by controlling the formulation and the formation process,

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That controls what the morphology would be.

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We say it again at column 8, and Moderna agrees, and they say it again.

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The four agreed so relied on Dr. Thompson's testimony that the 435 pattern, which is the same spec as the 069, if you produce these particles using that disclosure, you'll get the 95% non-laminar.

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I don't think he said that exactly, Your Honor, and the board didn't suggest that he did.

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What he said was that he would expect.

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The board didn't point to Dr. Thompson's testimony as further evidence to support the finding that the 069, if you inherently has the 95% non-lamilar,

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It cited his testimony for the proposition that he said one would expect that the 435 patent, without a particular discrete formation process, would obtain the 95% morphology.

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But an expectation is a statement of probability.

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That's not a statement that the 435 patent or 069 necessarily yields the 95% non-Lemmeler morphology.

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The board never said that he said that.

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And of course, he didn't say that.

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On the contrary, what he said a few

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pages later what did the board rely on dr. Thompson's testimony for that the board relied you're saying I can't follow what you're saying to me it looked like it was using it as evidentiary support

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to support the board's fact-finding that in fact there is inherent 95% non-lamilar in the 069 using DDM.

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And I agree that the board relied on Dr. Thompson's testimony, but where the board went wrong in its analysis, and this is most clearly shown in pages A32 through 34 of its opinion,

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is that the board conducts an enablement analysis.

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What it finds is that the prior art is sufficient to make the non-lamel or morphology, that one could have made the non-lamel or morphology based on the disclosures of the prior art.

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word for word, the finding that was reversed by this court in Roscoe versus Muir Light, where it's not enough to say that one could have made the claimed invention from the prior art, almost identical to the disclosure, to the finding from the district court that was reversed by this court in Galderma, where this court said it doesn't matter what the posa could have made or would have been able to make based on the prior art.

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That's the finding that the board ultimately had.

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Now Moderna runs away from that and says that's just one line of the opinion.

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Don't mind that the board conducted an enablement analysis.

[00:10:45] Speaker 01:
Is it necessary to manipulate any further steps outside of the art and the prior art in order to reach the morphology limitation?

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The evidence in the record is, yes, that the only process that provides the particular morphology that we claim is the one found at column 104 of our patent.

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That combination of solvents and ingredients and conditions is nowhere found in the prior art.

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put together, and we use a particular machinery, the lipobot process found in column 104, that is nowhere disclosed in the 069 patent, even with incorporation from the 031.

[00:11:22] Speaker 01:
So you're saying that there is no further manipulation that's required?

[00:11:26] Speaker 02:
Well, there's a manipulation that's provided in column 104, again, is the only example of something in the record that produces the non-Lamellar morphology.

[00:11:36] Speaker 00:
And the column 104, they describe that table as

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as DDM itself, does it not?

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They say the DDM process, and they first say column one afforded.

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So they say the DDM process as incorporated by 03-1, and here is DDM right here.

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So to me, it looks like it's linking whatever it's describing as part of the DDM method.

[00:12:05] Speaker 02:
All parties agreed below and here that DDM refers to a broad variety or category of processes.

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One example is the process set forth in Column 104.

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And what it says in Column 104, like Column 2, like Column 92, like Column 8, is that the DDM process, as described herein, produces the nondiluminal morphology.

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It does not say that every DDM process provides that morphology.

[00:12:29] Speaker 02:
The board never so found.

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There's no finding.

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by the board that all DDM processes yield the claim morphology.

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And that is precisely what this court required in the Galderma case.

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That's precisely what it required in the Roscoe case, as well as the Knopf case.

[00:12:45] Speaker 01:
You're into your rebuttal time.

[00:12:46] Speaker 01:
Do you want to reserve that time?

[00:12:47] Speaker 01:
Yes, please.

[00:12:48] Speaker 01:
Thank you so much.

[00:12:48] Speaker 01:
We'll restore you back in five minutes.

[00:12:50] Speaker 01:
I appreciate it.

[00:12:51] Speaker 01:
Thank you, Your Honor.

[00:12:54] Speaker 01:
Counselor Hunter.

[00:12:58] Speaker 04:
Good morning, and may it please the court?

[00:13:00] Speaker 04:
I'm Amy Wegmore, representing Appellee Moderna TXE.

[00:13:04] Speaker 01:
I'm sorry.

[00:13:04] Speaker 01:
Yes, Amy Wegmore.

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The board's decision in this case is based on factual findings that are supported by substantial evidence.

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In particular, the board made two critical findings.

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First, that Arbutus' prior 069 patent and its 127 patent disclose one or more of the same nucleic acid lipid particle

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formulations.

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That's found at appendix 42 and 45, and it's not contested by Arbutus.

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Second, that both patents disclose the same direct dilution process for making those particles.

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And that is found at appendix 45 and 46.

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Those critical findings led the board to an additional factual finding that the morphology limitation of claim one of the 127 patent

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is, quote, the natural result of following the disclosure of the 069 patent, which corresponds to the disclosure of the 127 patent.

[00:14:03] Speaker 01:
The word natural.

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I want to ask you about this natural result.

[00:14:08] Speaker 01:
How is natural result determined?

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How does that play a role in the world of CAN versus necessarily?

[00:14:20] Speaker 04:
Natural result is tantamount to necessarily.

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It is the standard that this court has applied repeatedly for inherency, including in the Shearing case, the King Pharmaceuticals case, and the Atlas Powder case, all of which are cited on our briefs.

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Natural result is

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the standard for in here and see and that is the standard and no no no manipulation or before the use of additional steps outside of the pen that's correct if you follow the prior art you will end up with this result and that is the finding

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that the board made.

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I do want to address Mr. Burl's argument about enablement.

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The opinion of the board very clearly makes these factual findings, very clearly finds inherency or a natural result.

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All of those are factual findings.

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And then it goes on to discuss the enablement of the prior art.

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And the reason is this.

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As the board made clear and as Arbutus does not contest, one is not required to show actual reduction to practice in order to establish

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anticipation.

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But if you're not relying on an actual reduction to practice, you do need to show enablement of the prior art.

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The board recognized that.

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That's set forth in the Bristol Myers-Squibb versus Benvenue Labs case, among others.

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And that portion of the opinion that Arbutus points to is where the board is doing exactly that.

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It first finds natural results.

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It acknowledges it has not relied upon an actual reduction to practice.

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nor need it, but then it addresses the fact that the prior does enable this disclosure, which is required for the finding.

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So this was not a misapplication of the enablement standard.

[00:16:00] Speaker 00:
When you say the word enable, I mean, is the board basically saying, when you make these particles described in the 069 using the direct dilution method, it's going to get you this 95% non-laminar property necessarily?

[00:16:18] Speaker 00:
Yes, that is correct.

[00:16:23] Speaker 00:
I mean, in maybe one sense, that sounds like enablement.

[00:16:26] Speaker 00:
But technically, that doesn't sound like a true enablement inquiry, as we commonly understand that.

[00:16:33] Speaker 04:
That is correct, Your Honor, that they are finding that the disclosure of the prior art will necessarily lead to particles with acclaimed morphology.

[00:16:43] Speaker 04:
But then they made clear, as Arbutus argued, that there was no actual reduction to practice in the 069 patent they were relying on.

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Rather, they're relying on the disclosure itself, the broad disclosure that is equally broad with the disclosure in the 127 patent, and finding that a person of ordinary scale would be able to make these claim particles following the disclosure of the 069 patent.

[00:17:07] Speaker 04:
So that was perfectly consistent with adherency law and the appropriate standard

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was applied.

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Now, I do want to address this issue of the process.

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There's no dispute about the formulations being the same.

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But there is, I think, a misunderstanding on Arbutus as part of what the direct dilution method is defined as in the 127 patent.

[00:17:30] Speaker 04:
If we look at appendix 228, the term direct dilution method appears with initial capitals.

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That is column 104.

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which Mr. Burrell referred to.

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And the direct dilution method is defined in that column as incorporating the 031 patent publication.

[00:17:54] Speaker 04:
Now significantly, the 127 patent also states at Appendix 178 that the... What column?

[00:18:05] Speaker 04:
In column, let's see,

[00:18:08] Speaker 04:
It's in column 3, yes, 3 lines 1 to 10.

[00:18:14] Speaker 04:
It says that it has surprisingly been found that lipid particles that are made using the initial caps direct dilution method, as described herein, have a novel non-Lamellar, i.e., non-bilear morphology.

[00:18:29] Speaker 04:
It's defining the term there and saying if you follow that method, it will lead to these non-Lamellar morphology particles

[00:18:36] Speaker 04:
And then when we come to column 104 at appendix 228, it defines direct dilution method, again, initial caps, as what is described in the 031 publication.

[00:18:48] Speaker 04:
So it's very clear that it's this broad method that the 031 defines that is being used.

[00:18:52] Speaker 00:
I heard your opposing counsel say

[00:18:55] Speaker 00:
when the specification refers to DDM as described herein, that is the signal to go look at table one and look at that particularized species of the direct evolution method.

[00:19:11] Speaker 00:
And so it's only that that they're referring to.

[00:19:14] Speaker 00:
Yes, that is not how column 104 reads.

[00:19:24] Speaker 04:
If you look at the initial caps direct dilution method, what follows that defined term is a reference to the 03-1 patent publication period.

[00:19:33] Speaker 04:
That's the sentence that appears.

[00:19:34] Speaker 04:
After that, there is a discussion of Table 1 and a specific example.

[00:19:39] Speaker 04:
And significantly, Dr. Thompson, Arbutus's expert, conceded that Table 1 is a subset of the 031 publication.

[00:19:50] Speaker 04:
It's not a new method.

[00:19:51] Speaker 04:
He conceded this, and the board relied on that testimony in its finding that the direct dilution method is disclosed in both the 069

[00:20:01] Speaker 04:
and the 127 patent in the same way.

[00:20:04] Speaker 04:
Table 1 is just a subset of the disclosure of 031, and Dr. Thompson conceded that.

[00:20:11] Speaker 00:
What is it that you think you have to prove to satisfy the inherency requirement?

[00:20:16] Speaker 00:
Is it you have to prove that any and every particle described in the 069 using any particular species of the direct dilution method

[00:20:28] Speaker 00:
will necessarily always get you the 95% morphology?

[00:20:34] Speaker 00:
Or is it that all we have to be convinced of is that one of the particles disclosed in the 069, using any one version of possibilities of the direct dilution method, will necessarily get you the 95% morphology?

[00:20:53] Speaker 04:
It's the latter.

[00:20:53] Speaker 04:
There needs to be a disclosure of at least one formulation

[00:20:58] Speaker 04:
that using at least one disclosed method leads to the claimed morphology.

[00:21:04] Speaker 04:
And that's exactly what the board found.

[00:21:06] Speaker 04:
It found that at least the 162 formulation, among others, was the same.

[00:21:11] Speaker 04:
And at least the direct dilution method, as described in the 069 patent, was the same, as the same description in the 127.

[00:21:20] Speaker 04:
That is enough, even if there are certain examples that don't have the same properties.

[00:21:27] Speaker 04:
Those are not using, by the way, direct dilution method.

[00:21:30] Speaker 04:
The examples that they give are the 240 or 230 formulation using the SDM method.

[00:21:37] Speaker 04:
So there's one example of that in the 127 pattern that doesn't meet the morphology.

[00:21:42] Speaker 04:
There's also a 1015 formulation where SDM doesn't meet the claim morphology.

[00:21:48] Speaker 04:
But that doesn't matter, because we have at least one, and in fact more than one, examples from the 069 patent, the 162, the 157, that when you use the direct dilution method, that you end up with the claim morphology.

[00:22:03] Speaker 04:
And figure 12 of the 127 patent is critical in this regard, because it shows that four different formulations, all of which are indisputably disclosed in the 069 patent,

[00:22:16] Speaker 04:
when you use direct dilution method, as again defined by reference to 031, lead to the claimed morphology of the claims at issue here.

[00:22:27] Speaker 04:
So it's not that everyone has to meet the limitation.

[00:22:31] Speaker 04:
You just need at least some specific disclosure, which there is here, that if you use this formulation and you follow this method, you will end up with the claimed morphology.

[00:22:42] Speaker 04:
And again, the King Pharmaceuticals case that we reference in our brief makes clear

[00:22:46] Speaker 04:
that when analyzing inherency, you compare the breadth of the disclosure in the prior patent to the patent at issue.

[00:22:54] Speaker 04:
You really need to disclose it only to the extent that the 127 patent does, and that's what King Pharmaceuticals holds, and that's exactly what happened here.

[00:23:04] Speaker 01:
Is there a shift in the burden here with respect to

[00:23:08] Speaker 01:
Inherency anticipation like, for example, do we or should we see a shift of burden to arbiters to disprove the inherency?

[00:23:20] Speaker 01:
That it was based off a mere assertion of similarity with the prior art.

[00:23:25] Speaker 04:
No, there is no shifting of the burden.

[00:23:27] Speaker 04:
In fact, the board made clear in its opinion that it was not shifting the burden, that it had found that the disclosure... I thought it had shifted the burden.

[00:23:37] Speaker 04:
No, it actually made clear that it was not shifting the burden in its opinion.

[00:23:42] Speaker 04:
And it said that

[00:23:45] Speaker 04:
The disclosure itself was there.

[00:23:49] Speaker 04:
But in any event, the board found this disclosure.

[00:23:52] Speaker 04:
Arbutus came back and said, what about this lipo bot?

[00:23:55] Speaker 04:
And then the board found that the lipo bot in table one was part of the disclosure of the 031 patent publication, citing to Dr. Thompson's

[00:24:06] Speaker 04:
testimony.

[00:24:07] Speaker 04:
So the burden of proof, if that's what Your Honor was asking about, was never shifted toward Arbutus, nor should it have been.

[00:24:14] Speaker 04:
Arbutus did try to argue against the disclosures being the same by citing to this lipobot embodiment, but the board rejected that on a factual basis, relying on the testimony of their own witness.

[00:24:31] Speaker 04:
In terms of the

[00:24:33] Speaker 04:
Dependent claims, they weren't addressed by Mr. Burrell.

[00:24:36] Speaker 04:
But I do want to address them briefly and note that the disclosure, again, is the very same in the two patents and or there's an inherent limitation that's being relied upon.

[00:24:48] Speaker 04:
So for the first two sets of dependent claims, we're talking about the claim three has the mRNA limitation.

[00:24:58] Speaker 04:
And the disclosure in the 127 patent

[00:25:01] Speaker 04:
is exactly the same as what is in the 069.

[00:25:04] Speaker 04:
Nucleic acid is defined in both patents as encompassing mRNA.

[00:25:09] Speaker 04:
That's all there is.

[00:25:10] Speaker 04:
There's nothing new in the 127 patent.

[00:25:13] Speaker 04:
With respect to claim 8, that's the fully encapsulated limitation, again, described and disclosed in exactly the same way in the two patents.

[00:25:22] Speaker 04:
Both patents state that the nucleic acid can be fully encapsulated in a lipid particle.

[00:25:27] Speaker 04:
And indeed, Dr. Thompson, their own expert,

[00:25:31] Speaker 04:
testify that the nucleic acid lipid particle does include a fully encapsulated lipid.

[00:25:38] Speaker 04:
So they don't dispute that is part of the definition of nucleic acid.

[00:25:44] Speaker 04:
In terms of the inverse hexagonal or cubic phase structure, which is claim 9, the only disclosure provided in support of that limitation in the 127 patent is figure 21, a theoretical drawing.

[00:25:59] Speaker 04:
And the statement, it is thought that the resulting non lamellar, i.e.

[00:26:03] Speaker 04:
non bilayer structure, particle has an inverse hexagonal or cubic phase structure.

[00:26:08] Speaker 04:
That's Appendix 181, column 9.

[00:26:12] Speaker 04:
And that is simply a statement of an inherent property, which is what the board found.

[00:26:16] Speaker 04:
Again, this is a factual finding that is supported by substantial evidence.

[00:26:21] Speaker 04:
And finally, with respect to claims 10 through 12,

[00:26:24] Speaker 04:
These are claimed ranges.

[00:26:26] Speaker 04:
The various ranges in the three claims are 10 to 50, 20 to 50, and 20 to 40% molar of cationic lipid.

[00:26:34] Speaker 04:
The board found that the 240 formulation, which is disclosed in the 069 patent and the 127 patent,

[00:26:43] Speaker 04:
falls within each of those ranges.

[00:26:46] Speaker 04:
So it's just a basic range situation where you have an embodiment within a particular range that anticipates.

[00:26:53] Speaker 04:
So there's really no issue as to the independent claims.

[00:26:57] Speaker 04:
The focus of Arbutus's arguments were primarily on this morphology limitation, which, as I've described,

[00:27:05] Speaker 04:
is supported, the board's finding that that is inherently anticipated, is supported by substantial evidence.

[00:27:11] Speaker 04:
It made factual findings of natural results.

[00:27:14] Speaker 04:
It made factual findings of the same disclosure of formulations and processes in the two patents.

[00:27:21] Speaker 04:
Arbutus should not be permitted to extend its patent monopoly based on the same disclosure in two different patents.

[00:27:29] Speaker 04:
The law is clear that a previously unappreciated property of a previously disclosed composition is not

[00:27:35] Speaker 04:
patentable, and the board's decision should be affirmed.

[00:27:42] Speaker 01:
Thank you.

[00:27:45] Speaker 01:
Thank you very much.

[00:27:50] Speaker 01:
Mr. Burrell, we're going to restore your time back to five minutes.

[00:27:55] Speaker 02:
Thank you very much, Your Honor.

[00:27:56] Speaker 02:
If I could start with Judge Chen's question to my opposing counsel, which is, what does Moderna have to prove?

[00:28:02] Speaker 02:
And that is set forth clearly in the Knopf case and in the Teba case.

[00:28:06] Speaker 02:
What they have to prove is that there is one particular formulation in the prior ARV with one particular formation process that necessarily and always yields the claim to dimension.

[00:28:18] Speaker 02:
You didn't hear that from Moderna and the board never found that because there is no specific formation process that's set forth in the 069.

[00:28:25] Speaker 02:
So what Moderna retreats to

[00:28:27] Speaker 02:
is the notion that the processes at a high level of generality are the same, because you have a direct dilution method in the prior art, and there's a direct dilution method in the 127 patent.

[00:28:38] Speaker 02:
That's exactly what this court encountered in Geliderma and in Knopf.

[00:28:42] Speaker 02:
And what did this court say?

[00:28:44] Speaker 02:
It said in Knopf that even though you had the same reactants in the same amounts in both the patent and in the prior art, that was not enough.

[00:28:53] Speaker 02:
Unless there is evidence that, quote, any reaction

[00:28:57] Speaker 02:
Any reaction meeting these quantity of reactant limitations would result in the product limitation.

[00:29:03] Speaker 02:
That is to say that Moderna has to prove here, in the absence of a particular formation process and formulation in the prior art, which it doesn't rely on, that any direct dilution method, that all direct dilution methods would work, unless there remain any doubt as to the applicable standard,

[00:29:20] Speaker 02:
This court did the same thing in Galderma, where the patent claimed certain efficacy from administering 1% ivermectin.

[00:29:28] Speaker 02:
And the prior art disclosed 1% ivermectin.

[00:29:31] Speaker 00:
What about the examples in column 109 of the 127, which

[00:29:37] Speaker 00:
you know, show varying formulations prepared by the direct deletion method, all of them clearly having 95% more than 95% non-lamilar.

[00:29:49] Speaker 02:
That's one formulation.

[00:29:51] Speaker 02:
That's where Moderna and the board fall off.

[00:29:54] Speaker 02:
That is not the same as all direct dilution methods.

[00:29:58] Speaker 02:
Column 109 and table 12, everything that my opposing counsel just said, are all data produced from a particular direct dilution method that everyone agrees is nowhere found in the prior article.

[00:30:12] Speaker 00:
Well, how do we know what you're saying is true?

[00:30:15] Speaker 00:
It just says, here are a bunch of formulations.

[00:30:19] Speaker 00:
prepared by the direct dilution method capital D, capital D, capital M. I think the patent is very clear that the data that

[00:30:28] Speaker 02:
that are provided, starting at column 104 and extending to column 109, are generated using the particular parameter set forth in table 1.

[00:30:37] Speaker 02:
That was not disputed below.

[00:30:39] Speaker 02:
And it's quite clear to both experts that that's what it's talking about.

[00:30:44] Speaker 02:
It's not talking about a general deleteric direct dilution method.

[00:30:47] Speaker 02:
Everyone agreed that those data were generated by the column 104.

[00:30:51] Speaker 02:
That's why Moderna called it the secret sauce, the single guiding principle about how these are made.

[00:30:57] Speaker 00:
It's not clear to me why that's necessarily everybody agrees about that.

[00:31:03] Speaker 02:
Well, I think why they agreed is perhaps a different question.

[00:31:09] Speaker 02:
But then it says, when it describes figure 1b and column 1b, it says equal volumes

[00:31:17] Speaker 02:
are blended, and then it says, and diluted directly.

[00:31:20] Speaker 02:
The ethanol is removed.

[00:31:22] Speaker 02:
As your honor knows, that's present tense language indicating that the process actually was used and carried out.

[00:31:28] Speaker 02:
It provides the only discrete process in this entire record that yields non-lemeller morphology.

[00:31:34] Speaker 02:
And then it provides data for what ensues when that process is carried out.

[00:31:39] Speaker 02:
And again, this court said clearly in the Galderma case that what you have when you have a broader disclosure of the prior art, and that's what Moderna is relying upon, the broad disclosure from the 031 incorporated in the 069, that what you need to show in those circumstances is that all formulations

[00:31:59] Speaker 02:
All of them will yield the claimed non-Lemmeler morphology.

[00:32:03] Speaker 02:
That is no less and no more than what this court required in Teva-Galderma, what it required in Knopf, what it required in the Roscoe case.

[00:32:12] Speaker 02:
They cite the King case and the Ingrid Crucifer's case.

[00:32:15] Speaker 02:
It's important that in the Henry cruciferous case, not only were the sprouts the same, this court proceeded to look at the processes of the prior art and recognize that the processes are exactly the same.

[00:32:26] Speaker 02:
As set forth in the Monroe reference, the process from the prior art cultivated the leaves before the two-leaf stage.

[00:32:33] Speaker 02:
This patent is clear that the particular formation processes matter.

[00:32:38] Speaker 02:
The patent says it at column two.

[00:32:40] Speaker 02:
It says it again at column eight.

[00:32:41] Speaker 02:
Moderna agrees at pages eight and 11 of its brief.

[00:32:44] Speaker 02:
Its own expert at 4170 and 4171 says that if you change the parameters, you wouldn't expect to make the non-Lemmeler morphology particles that we're talking about.

[00:32:53] Speaker 02:
And our experts said it too.

[00:32:55] Speaker 02:
So where the parameters matter, as they did in NOF, as they did in Teva-gal derma, and where the challenger is relying on a broader disclosure of the prior art, they must prove that every one necessarily yields it, or that there's a particularly disclosed formulation and process that yielded.

[00:33:11] Speaker 02:
The board found neither, and Moderna

[00:33:13] Speaker 02:
proves neither.

[00:33:14] Speaker 02:
And therefore, the decision should be reversed.

[00:33:16] Speaker 02:
And with respect to the dependent claim, if I could have just one sentence, there is no separate inherent anticipation analysis conducted for the dependent claims.

[00:33:23] Speaker 02:
That's required, and the board clearly erred as to the dependent claims, irrespective of what it did with respect to claim one.

[00:33:30] Speaker 01:
Thank you very much, Your Honor.

[00:33:31] Speaker 01:
Counsel, we thank you for your, for everybody's argument.